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Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

3. september 2009 opdateret af: Profil Institut für Stoffwechselforschung GmbH

Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily

This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Neuss, Tyskland, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • male or female subjects aged between 35 and 70 years, inclusive
  • type 2 diabetes with duration >6 months and <10 years
  • for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
  • HbA1c >=7.0% and <=10.0%
  • if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
  • written informed consent

Exclusion Criteria:

  • history or presence of cancer or any clinically relevant diseases
  • chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
  • recurrent hypoglycemia
  • abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
  • clinically relevant ECG findings at screening
  • treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
  • treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
  • any systemic or topical treatment with drugs known to influence glucose metabolism

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: insulin glargine + exenatide + metformin
Medicin: insulin glargine + exenatide + preexisting metformin
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin
Andre navne:
  • Byetta
  • Lantus
Eksperimentel: Insulin glargine + sitagliptin + metformin
Medicin: insulin glargine + sitagliptin + preexisting metformin
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin
Andre navne:
  • Januvia
  • Lantus
Aktiv komparator: insulin glargine + metformin
Medicin: insulin glargine + preexisting metformin
insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
Andre navne:
  • Lantus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast
Tidsramme: after 4 weeks of treatment
after 4 weeks of treatment

Sekundære resultatmål

Resultatmål
Tidsramme
mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes
Tidsramme: after 4 weeks of treatment
after 4 weeks of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Samarbejdspartnere

Sanofi

Efterforskere

  • Ledende efterforsker: Sabine Arnolds, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

3. september 2009

Først indsendt, der opfyldte QC-kriterier

3. september 2009

Først opslået (Skøn)

4. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. september 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2009

Sidst verificeret

1. september 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 49/0316-Adjunct

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med insulin glargine + exenatide + preexisting metformin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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